Clinical Research Guidelines & Regulatory Framework.pptx

CLINICAL RESEARCH & REGULATORY
FRAMEWORK
A COMPREHENSIVE OVERVIEW OF GLOBAL AND INDIAN REGULATIONS
Presented by: Ms. Harshada Kiran Sonawane
(B. Pharm, M. Pharm, DRA & IPR)
Assistant Professor (Dept. of Regulatory Affairs)
Sanjivani College of Pharmaceutical Education and Research, Kopargaon

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INTRODUCTION TO CLINICAL RESEARCH GUIDELINES
• Definition of Clinical Research
Clinical research is a branch of healthcare science that determines the safety and effectiveness
of medications, devices, diagnostic products and treatment regimens intended for human use.
It aims to advance medical knowledge by studying people, either through direct interaction or
through the collection and analysis of blood, tissues, or other samples.

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IMPORTANCE OF REGULATORY COMPLIANCE
• Avoiding legal risks and penalties
• Improving the quality and safety of patient care
• Ensuring proper procedures and patient safety
• Reducing waste, fraud, and abuse
• Maintaining public trust and avoiding penalties
• Protecting the privacy and security of health information

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KEY INTERNATIONALAND NATIONAL GUIDELINES
• ICH. Guidance for Industry. E6 Good Clinical Practice. Consolidated Guidance. April
1996 (E6R1)
• CIOMS Guideline for Epidemiological Research 1991
• UNESCO Universal Declaration on Bioethics and Human Rights (2006)
• CIOMS. International Ethical Guideline for Biomedical Research Involving Human
Subjects (1993, revised 2002)

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GOOD CLINICAL PRACTICE (GCP) GUIDELINES
• A standard for the design, conduct, performance, monitoring, auditing, recording,
analyses, and reporting of clinical trials that provides assurance that the data and reported
results are credible and accurate, and that the rights, integrity, and confidentiality of trial
subjects are protected

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THE NUREMBERG CODE
Origin of the Nuremberg Code
• Historical Context: Developed in response to Nazi medical experiments conducted
during World War II.
• Legal Foundation: Formulated in 1947 during the Nuremberg Trials, specifically the
Doctors' Trial, where 23 Nazi physicians and administrators were prosecuted for
unethical human experimentation.
• Purpose: To establish ethical standards for conducting research involving human subjects
and to ensure protection from exploitation and harm.

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THE NUREMBERG CODE
Principles of the Nuremberg Code
Voluntary Consent is Essential
Participants must freely give informed consent without coercion or deception.
They must fully understand the nature, duration, and purpose of the experiment.
Fruitful Results for Society
Research must aim to yield results that benefit society and cannot be obtained by
other methods.
Based on Prior Animal Studies
Human experiments must be grounded in animal research and the natural history
of the disease.
Avoidance of Unnecessary Physical and Mental Suffering
Experiments should be designed to minimize risk and suffering.

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THE NUREMBERG CODE
No Experiment if There is a Prior Reason to Believe It May Cause Death or
Disability
Exception only if the researchers also serve as subjects.
Risk Must Be Proportional to the Importance of the Problem
The expected humanitarian benefit must justify the risk.
Proper Preparations and Adequate Facilities
The environment should ensure the safety of participants.
Conducted by Scientifically Qualified Persons
Only trained and competent personnel should conduct research.

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THE NUREMBERG CODE
Subjects Can Withdraw at Any Time
Participants must have the freedom to quit the study at any stage without penalty.
Researchers Must Be Prepared to Terminate the Study
If continuing the experiment is likely to cause harm or death, researchers must stop
it immediately.

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THE NUREMBERG CODE
Significance:
1. First international document to set standards for ethical human research.
2. Served as the foundation for later guidelines like the Declaration of Helsinki and
Good Clinical Practice (GCP).

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THE DECLARATION OF HELSINKI
• Role of Medical Association (WMA)
• WHO: The WMA is an INTERNATIONAL organization of physicians established in
1947
• PURPOSE: Formulated to ensure ethical standards in medical practice and research
worldwide
• ACTION: In 1964, the WMA adopted the Declaration of Helsinki as a set of ethical
principles for medical research involving human subjects
• REVISIONS: Updated multiple times to reflect changes in research practices (in
1975, 1983, 2000, 2008, 2013
• CURRENT VERSION: October 2013

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THE DECLARATION OF HELSINKI
Respect for Individuals
Upholds autonomy, privacy, and dignity of research participants.
Primacy of the Patient's Well-being
The interests of the subject must always take precedence over the interests of science
and society.
Scientific Soundness
Research must be scientifically justified and based on thorough literature and pre-
clinical (animal) studies.

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KEY ETHICAL GUIDELINES IN THE DECLARATION OF
HELSINKI
• The Declaration expands on the Nuremberg Code and emphasizes physician
responsibility, patient welfare, and research ethics.

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REGULATORY FRAMEWORK – GLOBAL PERSPECTIVE
Overview of Regulatory Authorities
FDA (USA), EMA (Europe), PMDA (Japan), CDSCO (India), etc
ICH-GCP (E6 R2)
Standardization of clinical trials globally
FDA Guidelines (USA)
IND application, IDE, NDA process, 21 CFR Parts 50, 56
WHO Role & Guidelines
WHO Handbook, ICTRP registry

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THANK YOU!

Clinical Research Guidelines & Regulatory Framework.pptx

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